Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses

Sponsor

National Healthcare Group, Singapore (Other)

Overall Status

Completed

CT.gov ID

NCT05410691

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cannulation of complex arteriovenous fistula (AVF) or graft (AVG) is a challenge to renal nurses. Ultrasound (US) guidance on central and peripheral venous access visualisation has been widely adopted in nephrology and shown to reduce complications of vascular interventions. With broader adoption of handheld US devices in clinical services, renal nurses could acquire this point-of-care technique to increase the successful cannulation rate while facilitating confidence build-up during training and practice. We aim to evaluate the use of handheld US on difficult AVF/AVG cannulation in a hospital-based dialysis unit.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Complication Dialysis; Complications Vascular Access Site Haematoma Vascular Access Complication Dialysis Access Malfunction Fistula Graft Av	Device: Handheld US device	N/A

Detailed Description

We conducted a prospective randomised controlled study from January 2021 to January 2022. Ten renal nurses were trained by an interventional nephrologist before patient recruitment and had completed a pre- and post-training questionnaire on their confidence level. Fifty haemodialysis patients with complex AVF were randomised to US-guided or conventional cannulation. The total time spent on cannulation and patients' pain scores were also collected.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised controlled trialRandomised controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses - A Randomised Controlled Trial

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Conventional AVF/AVG cannulation by renal nurses in standardised manner
Active Comparator: ultrasound guided AVF/AVG cannulation by renal nurses by handheld US device	Device: Handheld US device Handheld US-guided AVF/AVG cannulation

Arm

Intervention/Treatment

No Intervention: Conventional

AVF/AVG cannulation by renal nurses in standardised manner

Active Comparator: ultrasound guided

AVF/AVG cannulation by renal nurses by handheld US device

Device: Handheld US device

Handheld US-guided AVF/AVG cannulation

Outcome Measures

Primary Outcome Measures

percentage of successful cannulation [from skin contact to actual start of dialysis]

Secondary Outcome Measures

pre-cannulation assessment time [from patient physical contact to the time before needling thru skin]
time taken to assess the AVF/AVG with either US or clinical examination before cannulation
cannulation time [skin contact by needle to succesful aspiration of blood from needle]
patients' pain score [needle to skin to end of dialysis session]
10cm visual analogue scale
complications [from skin contact to actual start of dialysis]
need for a temporary central venous catheter, single-needle dialysis, or infiltration (e.g. haematoma) that hastened the use of AVF/AVG for the same dialysis session

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First-time cannulation, 2. Post-angioplasty or thrombectomy, 3. Partial stenosis confirmed with imaging or by vascular surgeons/interventional radiologists, 4. Failed cannulation by dialysis nurses at community centres, 5. Bruises or haematoma around AVF/AVG, 6. Presence of clots in AVF/AVG and 7. Deep-seated access by physical examination.